CTP 016: Bioethics in Clinical Research with Dr. Lindsay McNair

Our guest on the show is Dr. Lindsay McNair, Chief Medical Officer for the WIRB-Copernicus Group, a central Institutional Review Board (IRB) overseeing more than 200,000 clinical research protocols and more than 2,700 institutions and 700 local Institutional Biosafety Committees. In her current role, Dr. McNair develops strategic partnerships with pharma/biotech companies for comprehensive ethical and clinical services. She oversees a consulting group which provides consultation on human research protection, ethical trial design, protocol development, development of ethical clinical research policy and practices and much more. Dr. McNair has more than 15 years of experience in clinical research and drug development strategy. She has designed and provided medical monitoring for Phase 1-4 clinical studies in a variety of therapeutic areas, including multiple oncology indications, hepatitis C, multiple inflammation indications (psoriasis, multiple sclerosis) and other areas. Dr. McNair is also an adjunct Assistant Professor at Boston University and teaches in the School of Public Health and in the Master’s of Clinical Investigation graduate programs, on the design and conduct of clinical research studies. She speaks frequently on the ethical conduct of clinical research studies as part of pharmaceutical drug development and improving interactions between ethics committees/ research review boards and the pharmaceutical industry. Dr. McNair graduated from the University Of Connecticut School Of Medicine and trained in general surgery at Boston University Medical Center. She has a Master’s in Public Health (Biostatistics/Epidemiology and Health Policy), and a Master’s of Science in Bioethics (research ethics). Please join me in welcoming Dr. Lindsay McNaire on the Clinical Trial Podcast. This episode is brought to you by CBI Events. The team at CBI has put together a Digital Therapeutics event in New York City on December 3-4, 2018. Topics range from strategies for new digital health projects to perspectives from the venture capital community on investment requirements for digital therapeutics. Whether you’re a pioneer in this space or want to know just the right amount of information to get started, this event is going to value packed for you. Some benefits from your participation in this event include: Learning strategies on how to ensure data integrity Understanding regulatory approaches to digital therapeutics and how to seamless approval in all regions Finding out about payer approval requirements and uncovering changing business models Collaborating with others on standard definitions and approaches to what constitutes a digital therapeutic And much, much, more. If you want to learn and network with others in the Digital Therapeutics space, you should attend the 2018 event in New York City on December 3-4, 2018. As a listener to this podcast, I’ve got an exclusive $500 discount to this event. When I mean exclusive, it really is exclusive. So head over to http://www.cbinet.com/digitaltherapeutics and use the code CTP500 at check-out to get your $500 discount. Register today to get your exclusive $500 off your event ticket using the code CTP500. This offer is only available to the Clinical Trial Podcast listeners.